Siemens has established a new molecular imaging division that will tie together its traditional nuclear imaging capabilities with the PET expertise of recently acquired CTI Molecular Imaging, the leader in the field, according to company officials.
The German imaging giant is taking the step with the goal of pushing the technology and applications closer to pharmacogenomics and drug development, a move that will align it more closely with rival GE Healthcare, which has staked an early claim in the nascent in vivo-in vitro market.
Siemens has been developing products for the molecular imaging market for a few years and has had a collaboration for the past two years with Ralph Weissleder and colleagues at the Center for Molecular Imaging Research at Massachusetts General Hospital. Following its recent acquisition of CTI for roughly $1 billion, Siemens said the new division, called Siemens Medical Solutions Molecular Imaging, would focus on PET and single photon emission computed tomography-based molecular imaging technologies.
"We lack a mechanism for rapidly — or even slowly — tracing the response of cancer patients [to potential therapies] in clinical trials. We want to see imaging technologies put to use here" to gauge such endpoints as tumor size reduction.
Beside GE Healthcare, Philips Medical Systems is pursuing molecular imaging technologies' slice of the molecular diagnostics market — currently estimated at $1 billion to $1.5 billion with an annual growth rate of 20 percent.
What's at stake is not only a greater share of the traditional CT, PET and MRI markets, which employ these platforms to identify diseases, but also a potentially more lucrative market in tracking patient response to therapy and drug research. Earlier this year, US Food and Drug Administration officials said that they would like to see imaging technologies applied to the drug development process.
"We lack a mechanism for rapidly — or even slowly — tracing the response of cancer patients [to potential therapies] in clinical trials," Janet Woodcock, acting deputy commissioner for operations at the FDA, said in April at the Molecular Medicine Tri-Conference in San Francisco (see BioCommerce Week 4/28/2005). "We want to see imaging technologies put to use here" to gauge such endpoints as tumor size reduction.
Imaging technologies are also part of the FDA's Critical Path initiative, a document issued last March that highlights the FDA's belief that medical product development has fallen behind advances in basic sciences.
"New imaging technologies will ultimately contribute important biomarkers and surrogate end points, but how soon these new tools will be available for use will depend on the effort invested in developing them specifically for this purpose," the FDA said in the document.
Eyeing In Vitro Dx?
While Siemens' interest in molecular diagnostics is not surprising, what may be more interesting is that the company is considering a potential tie-in between its in vivo imaging products and in vitro diagnostic offerings in the future.
David Wang, director of molecular medicine business development at Siemens Medical Solutions, told BioCommerce Week that the firm sees the future of diagnostics as a convergence of traditional and molecular diagnostics. "In that case, we asked ourselves if we should look strategically into both in vivo and in vitro diagnostics," he said (see this week's Q&A for more comments from Wang on Siemens' participation in the molecular biology field).
Siemens currently does not have an in vitro diagnostics business, but it is working on a personalized healthcare program at Siemens Corporate Research in Princeton, NJ. And Wang suggested that the firm's evaluation of in vitro diagnostics ties in with those efforts.
"We're taking a patient-centric approach and looking at all sorts of different forms of data and how to integrate them to care for that patient," said Daniel Fasulo, a project manager in the integrated data systems department who is working on the program. He told BioCommerce Week that the project would integrate molecular biology tools such as protein biomarkers and genotyping data along with imaging technologies, such as MRI, and clinical variables and demographic data about the patient.
The firm has been very active over the past few years in building a presence in the molecular biology field, starting with a collaboration signed in 2001 with German firm november to develop a DNA-based electrochemical diagnostic system. Since then, it has partnered with Biomax Informatics on gene expression modeling and simulation, and last fall the firm announced a collaboration with the genotyping and gene-expression tool vendor Sequenom to develop molecular diagnostic platforms based on Sequenom's MassArray technology.
Siemens also recently purchased the biochip technology division of Infineon — a German semiconductor firm that is itself a spin off of Siemens — furthering its patent estate and development activities in the molecular diagnostics field. Mohammad Naraghi, senior vice president of business development at Siemens Medical Solutions, told BioCommerce Week sister publication BioArray News that the firm has "had activities to develop biochips for a couple of years now" (see BAN 06/15/2005).
Infineon's chip technology is incorporated into Siemens' Quicklab, a handheld diagnostics device that runs DNA- or protein-based experiments on a smart card. The system has not been commercially launched yet, but it is clearly a part of Siemens' strategy to play a greater role in the molecular biology field.
Philips, GE Advancing
Molecular Imaging Programs
Like Siemens, Philips is engaged in expanding its offerings into the molecular biology tools field, as well. "Philips is looking at the broader stroke of molecular medicine and developing expertise in both molecular diagnostics as well as in molecular imaging," David Rollo, chief medical officer of Philips' nuclear medicine group, told BioCommerce Week.
He noted that Philips has a molecular medicine group employing roughly 100 people that are focused on molecular diagnostics. According to Rollo, the firm has been collaborating with academic institutions on biomarker development and expects that products from some of those collaborations would be further developed by Philips' cardiac monitoring services division.
Rollo said that the firm would likely manufacture devices to analyze biomarkers and collaborate with others who would make diagnostic kits. He said the molecular imaging products it sells would "cut across all of our current modalities — that includes nuclear medicine, PET and SPECT, ultrasound, MR, and CT. But we're also becoming more interested and excited by the potential of optical imaging, which we believe has the ability to also have molecular diagnostic agents that can be evaluated in areas like the breast and tissues that are close to the surface of the body."
GE Healthcare officials did not return a request for comment. The firm has been working on molecular imaging products for several years. A little over a week ago the firm announced the launch of its Discovery STE, a combination PET/CT molecular imaging system. Along with the technologies it acquired through its purchase of Amersham last year, including imaging agents and the CodeLink microarray platform, GE Healthcare has the product offerings that would make it a natural competitor in a personalized healthcare market where molecular imaging and molecular diagnostic technologies will work in concert.
— Edward Winnick ([email protected])